UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004193 |
|---|---|
| Receipt number | R000005037 |
| Scientific Title | Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study) |
| Date of disclosure of the study information | 2010/09/22 |
| Last modified on | 2012/03/11 18:04:28 |
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Basic information
Public title
Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)
Acronym
Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)
Scientific Title
Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)
Scientific Title:Acronym
Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of metformin and lifestyle interventions as an initial treatment in newly diagnosed Japanese patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in glycated hemoglobin (HbA1c) at 16 weeks after the initiation of the treatment
Key secondary outcomes
Change in body weight, fasting plasma glucose, glycated albumin, total cholesterol, triglyceride, HDL-cholesterol, liver enzymes, and an incidence of adverse effects during treatment.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Newly diagnosed patients with type 2 diabetes aged 20 years and older.
Key exclusion criteria
Type 1 diabetes.
Patients contraindicated to metformin.
Patients judged not to be eligible by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Sumitani |
Organization
Nissay Hospital
Division name
Center for Preventive Medicine
Zip code
Address
6-3-8 Itachibori, Nishi-ku, Osaka, Osaka
TEL
06-6543-3581
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Sumitani |
Organization
Nissay Hospital
Division name
Center for Preventive Medicine
Zip code
Address
6-3-8 Itachibori, Nishi-ku, Osaka, Osaka
TEL
06-6543-3581
Homepage URL
sa_sumitani@yahoo.co.jp
Sponsor or person
Institute
Nissay Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本生命済生会付属日生病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://medical.med.tokushima-u.ac.jp/jmi/vol59/pdf/v59_n1-2_p166.pdf
Number of participants that the trial has enrolled
Results
Satoru Sumitani, Shinya Morita, Yoshihiko Utsu, Kosuke Mukai, Shunji Miki, Bunzo Sato, Hideji Nakamura, Soji Kasayama. Effectiveness of metformin and lifestyle interventions asan initial treatment in Japanese patients with newly diagnosed type 2 diabetes : a prospective observational study. J. Med. Invest. 59 : 166-173, February, 2012
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cohort study
Management information
Registered date
| 2010 | Year | 09 | Month | 11 | Day |
Last modified on
| 2012 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005037
